Predictive Value of PET CT in the Histologic Lymph Node Status of Patients With Squamous Cell Carcinoma of the Oral N0 Clinical and Radiological Cavity.

NCT03947892 | Unknown

• 2 other identifiers: 38RC19.0642019-A00883-54
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Squamous cell carcinoma of the VADS represents the majority of cancers in ENT. Metastatic lymph node involvement is an important prognostic factor. In N0 patients clinically and scanographically, the prevalence of cervical lymph node metastasis remains important. Only the anatomopathological analysis of cervical lymph node dissection confirms the presence of a micro-metastasis. However, new criteria of interpretation in nuclear medicine seem promising in the detection of lymph node lesions not detectable in traditional imaging. The main objective of this study is to study the positive predictive value (PPV) of CT scans in the anatomo-pathological analysis of N0 clinical and radiological or N + unilateral neck ganglia in patients with squamous cell carcinoma of the oral cavity.

Conditions

Squamous Cell Carcinoma of the Oral; Clinically Node-Negative and Radiology

Outcome Measures

Primary Outcomes (1)

• metastatic lymph node involvement

  The outcome is analyzing histologic metastatic lymph node. The outcome data table will include the presence of histologic metastatic lymph node, localization of the lymph invaded, presence of capsular rupture, and preoperative TEP CT data.

  30 days

Interventions

PET-CT DIAGNOSTIC_TEST

A PET-CT scan will be performed systematically for all patients included with the SUVmax, SUV peak, MTV of the lesion, and up to 3 suspicious ganglia during the visual analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population selected is that of any patient with squamous cell carcinoma of the oral cavity classified N0 clinical and radiological or unilateral N +, M0, not challenged for tumor resection surgery and bilateral cervical dissection. They will benefit in their assessment of extension of a PET-CT. Patients will be selected during an ENT or maxillofacial consultation. They will receive clear and appropriate information from the study. They will decide whether to participate in the study.

You may qualify if:

• st localization of squamous cell carcinoma of the oral cavity.
• Any tumor T according to the 2017 classification, N0 clinical and radiological or N + unilateral, M0
• Not challenged for tumor resection surgery and bilateral dissection.

You may not qualify if:

• age \<18 years
• opposition of the curator concerning the person under guardianship
• subject under guardianship or deprived of liberty
• antecedent treatment of cancer of the upper aero-digestive tract (surgery, radiotherapy, chemotherapy)
• any current treatment for another cancer site

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Related Publications (8)

• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

  PMID: 23335087 BACKGROUND

• Arya S, Rane P, Deshmukh A. Oral cavity squamous cell carcinoma: role of pretreatment imaging and its influence on management. Clin Radiol. 2014 Sep;69(9):916-30. doi: 10.1016/j.crad.2014.04.013. Epub 2014 Jun 5.

  PMID: 24908285 BACKGROUND

• Schoder H, Carlson DL, Kraus DH, Stambuk HE, Gonen M, Erdi YE, Yeung HW, Huvos AG, Shah JP, Larson SM, Wong RJ. 18F-FDG PET/CT for detecting nodal metastases in patients with oral cancer staged N0 by clinical examination and CT/MRI. J Nucl Med. 2006 May;47(5):755-62.

  PMID: 16644744 BACKGROUND

• Ng SH, Yen TC, Chang JT, Chan SC, Ko SF, Wang HM, Lee LY, Kang CJ, Wong AM, Liao CT. Prospective study of [18F]fluorodeoxyglucose positron emission tomography and computed tomography and magnetic resonance imaging in oral cavity squamous cell carcinoma with palpably negative neck. J Clin Oncol. 2006 Sep 20;24(27):4371-6. doi: 10.1200/JCO.2006.05.7349.

  PMID: 16983105 BACKGROUND

• Stoeckli SJ, Steinert H, Pfaltz M, Schmid S. Is there a role for positron emission tomography with 18F-fluorodeoxyglucose in the initial staging of nodal negative oral and oropharyngeal squamous cell carcinoma. Head Neck. 2002 Apr;24(4):345-9. doi: 10.1002/hed.10057.

  PMID: 11933176 BACKGROUND

• Lee SJ, Choi JY, Lee HJ, Baek CH, Son YI, Hyun SH, Moon SH, Kim BT. Prognostic value of volume-based (18)F-fluorodeoxyglucose PET/CT parameters in patients with clinically node-negative oral tongue squamous cell carcinoma. Korean J Radiol. 2012 Nov-Dec;13(6):752-9. doi: 10.3348/kjr.2012.13.6.752. Epub 2012 Oct 12.

  PMID: 23118574 BACKGROUND

• Ryu IS, Kim JS, Roh JL, Cho KJ, Choi SH, Nam SY, Kim SY. Prognostic significance of preoperative metabolic tumour volume and total lesion glycolysis measured by (18)F-FDG PET/CT in squamous cell carcinoma of the oral cavity. Eur J Nucl Med Mol Imaging. 2014 Mar;41(3):452-61. doi: 10.1007/s00259-013-2571-z. Epub 2013 Oct 1.

  PMID: 24081448 BACKGROUND

• Chung MK, Jeong HS, Son YI, So YK, Park GY, Choi JY, Hyun SH, Kim HJ, Ko YH, Baek CH. Metabolic tumor volumes by [18F]-fluorodeoxyglucose PET/CT correlate with occult metastasis in oral squamous cell carcinoma of the tongue. Ann Surg Oncol. 2009 Nov;16(11):3111-7. doi: 10.1245/s10434-009-0621-3. Epub 2009 Jul 16.

  PMID: 19609618 BACKGROUND

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Claire DUCROZ

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: August 21, 2019
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)